NCT01562132

Brief Summary

The purpose of this study is to determine if treatment with two medicines in combination (fluconazole and flucytosine) is safe as compared with one medicine alone (fluconazole) for the treatment of an early infection with a fungus called cryptococcus.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 31, 2015

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

March 21, 2012

Results QC Date

July 31, 2015

Last Update Submit

September 1, 2021

Conditions

Cryptococcal Infection Disseminated

Keywords

cryptococcusHIV

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Alive at 12 Weeks

    12 weeks

Secondary Outcomes (10)

  • Number of Participants Alive at 2 Weeks

    2 weeks

  • Survival at 24 Weeks

    24 weeks

  • Number of Individuals Who Develop Cryptococcal Meningitis

    24 weeks

  • Number of Individuals Who Develop Immune Reconstitution Inflammatory Syndrome Due to Cryptococcus

    24 weeks

  • Achieve Targeted Recruitment, Retention and Adherence Rates

    24 weeks

  • +5 more secondary outcomes

Study Arms (2)

5FC plus fluconazole

EXPERIMENTAL

Combination therapy with oral fluconazole and flucytosine

Drug: Flucytosine and fluconazole

fluconazole alone

ACTIVE COMPARATOR

Fluconazole monotherapy

Drug: Fluconazole

Interventions

Flucytosine and fluconazoleDRUG

Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily

Also known as: Ancobon, Diflucan
5FC plus fluconazole
FluconazoleDRUG

fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily

Also known as: Diflucan
fluconazole alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to give informed consent
  • Age \> 18 years
  • HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines
  • CD4+ T-cell count ≤100 cells/µl
  • Serum CrAg titer≥1:2
  • Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits

You may not qualify if:

  • clinical meningitis:
  • clinical sepsis:
  • hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system
  • a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis
  • a history of stroke or other infection of the central nervous system
  • a seizure within the last 2 months
  • currently taking or ever taken antiretroviral therapy
  • currently taking anti-tuberculous therapy
  • currently or recently (\<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications
  • pregnant or breast-feeding
  • alanine aminotransferase concentration more than 3 times the upper limit of normal
  • neutrophil count \<1000x103 cells/mL
  • hemoglobin \<8g/dL
  • platelet count \<100,000x 103 platelets/mL
  • creatinine clearance ≤50 ml/min
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family AIDS Care and Education Services

Kisumu, Nyanza, Kenya

Location

Family AIDS Care and Education Services

Sindo, Nyanza, Kenya

Location

MeSH Terms

Interventions

FlucytosineFluconazole

Intervention Hierarchy (Ancestors)

CytosinePyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzoles

Results Point of Contact

Title
Dr. Ana-Claire Meyer
Organization
Yale University
ana-claire.meyer@yale.edu
203-737-8372

Study Officials

  • Ana-Claire L Meyer, MD, MSHS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Mark A Jacobson, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Judith K Kwasa, MBChB MMed

    University of Nairobi

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

September 29, 2021

Results First Posted

August 31, 2015

Record last verified: 2021-09

Locations

KE(2)